VISEN Pharmaceuticals Makes Inaugural CIIE Debut, Advancing 'Global Innovation, China Acceleration' Strategy with Two Breakthrough Endocrine Therapies

On November 5, 2025, VISEN (2561.HK), an innovative pharmaceutical company in the field of endocrinology, made its debut as an exhibitor at the 8th China International Import Expo (CIIE). The company unveiled two global innovative drugs: palopegteriparatide, a “first-in-class” therapy recognized as a “CIIE Featured Product” for its exceptional innovation, and lonapegsomatropin, a drug positioned to become a “potential best-in-class” therapy, which was also exhibited for the first time. This strong presence fully demonstrates VISEN’s strategic commitment to “Global Innovation, Accelerated in China.”

During the China International Import Expo (CIIE), VISEN Pharmaceuticals entered into a strategic cooperation agreement on dual-chamber lyophilized formulation technology with Tofflon Science and Technology Group Co., Ltd. (300171.SZ, hereinafter referred to as “Tofflon”), a leading domestic pharmaceutical equipment manufacturer. Additionally, VISEN signed an industrial synergy agreement with the Administrative Committee of the Lingang New Area and the Logistics and Trade Platform of Lingang Group. These milestones mark further implementation of VISEN’s strategy of “Global Innovation, Accelerated in China.” Through these signings, VISEN has demonstrated its firm commitment to rooting itself in the Chinese market, actively embraced the CIIE spirit of “Sharing and Cooperation,” and contributed to enabling more Chinese patients to benefit sooner from cutting-edge global medical advancements.

Palopegteriparatide is the world’s first and only hormone replacement therapy approved for the treatment of chronic hypoparathyroidism (HP) in adults. As a globally leading innovative drug featured among the “CIIE Star Products,” it underscores the China International Import Expo’s strong recognition of medications with truly breakthrough clinical significance. Palopegteriparatide not only fills the long-standing gap in hormone replacement therapy for HP in China, but also breaks the decades-long therapeutic stalemate in this disease area, bringing a revolutionary breakthrough to clinical practice.

According to public information, adult chronic hypoparathyroidism (HP) is an endocrine disorder caused by insufficient secretion or impaired action of parathyroid hormone (PTH). The potential patient population in China reaches 400,000, with long-standing unmet clinical needs. In conventional treatment, patients receive high-dose oral supplementation of calcium and active vitamin D or its analogs for symptomatic management. While this approach can alleviate symptoms of hypocalcemia to some extent, it does not fundamentally address the metabolic abnormalities and complications arising from PTH deficiency.

Compared with traditional symptomatic treatment regimens, PTH replacement therapy, pioneered by palopegteriparatide, targets the underlying cause by supplementing deficient PTH and maintaining PTH levels consistently within the normal physiological range, representing a more physiologically aligned and ideal therapeutic approach for hypoparathyroidism (HP).

Currently, palopegteriparatide has successively received marketing approval and been commercialized by the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. Food and Drug Administration (FDA). In September 2025, palopegteriparatide was approved in Boao, Hainan, as a clinically urgent drug for clinical use at Ruijin Hospital Hainan Branch, with the first prescription issued at the hospital in October of the same year. Benefiting from the “Four Special Permissions” policy of the Boao Lecheng International Medical Tourism Pilot Zone—namely, special permissions for medical treatment, research, business operations, and international medical exchanges—palopegteriparatide has successfully established a critical pathway from global innovation to implementation in China, creating an efficient channel for Chinese patients to access global innovative achievements simultaneously without having to travel abroad.

To accelerate the introduction of global innovative therapies into China and build a localized, high-quality closed loop encompassing R&D, manufacturing, and sales, VISEN actively responds to this year’s China International Import Expo (CIIE) theme, “Embracing Openness to Create New Opportunities, Fostering Cooperation to Share a New Future.” The company is committed to making innovative biological products of top-tier global quality accessible to Chinese patients, thereby accelerating the transformation of “global novelties” showcased at the CIIE into “trusted medicines” readily available to patients in China.

During the China International Import Expo (CIIE), VISEN announced the formal signing of a strategic partnership with Tofflon, marking a solid step forward in its layout for localized commercial production of innovative drugs. By integrating Tofflon’s leading process equipment and system solutions, both parties are committed to providing Chinese patients with biologics that meet top-tier global quality standards.

The core of this collaboration lies in the development and application of dual-chamber lyophilized formulation technology. Through a physical isolation design within a sealed container, the lyophilized drug and diluent are stored independently within the injection device. Prior to injection, a simple press completes the traditionally cumbersome process of reconstituting the medicinal solution. In the field of high-end biologics, it is often challenging to balance the stability of active ingredients in injectables with ease of use. VISEN’s proprietary patents related to dual-chamber formulations effectively address this critical pain point, paving the way for the first implementation of dual-chamber lyophilization technology in China, filling the domestic technological gap in this area, and providing an advanced drug delivery solution.

The strategic partnership with Tofflon represents a deepened implementation of VISEN’s “Global Innovation, China Acceleration” strategy. The construction of China’s first dual-chamber lyophilized formulation production line is not only poised to resolve key technical bottlenecks in the industrialization of biopharmaceuticals, but also serves as a vivid demonstration of the profound integration between high-end manufacturing and the biomedical industry.

Notably, as VISEN’s first product pending approval in China, Lonapegsomatropin utilizes TransCon (Transient Conjugation) technology to enable slow and controlled release of active molecules that are structurally identical to natural growth hormone. Furthermore, dual-chamber lyophilization technology enhances the stability and ease of use of Lonapegsomatropin. Without the need for preservatives, Lonapegsomatropin can be stored at room temperature (≤30°C) for up to six months, offering significant convenience for both patient administration and drug storage.

The marketing application for Longpei growth hormone was accepted by the China National Medical Products Administration (NMPA) in March 2024 and is expected to be approved within 2025, potentially providing a best-in-class therapeutic option for children with growth hormone deficiency in China.

VISEN’s debut at the China International Import Expo (CIIE) vividly embodies its strategy of “Global Innovation, Accelerated in China.” It also marks a pivotal transition for VISEN as it drives global innovative products, such as lonapegsomatropin, from “exhibition showcases” to “marketable commodities,” and from “technology introduction” to “local co-creation.” Leveraging the CIIE as a world-class platform, VISEN is continuously promoting the deep integration of globally leading therapies with clinical needs in China.

Looking ahead, VISEN will continue to uphold the CIIE spirit of “sharing opportunities and achieving win-win cooperation,” accelerating the domestic industrialization of multiple “global first-in-class” products, including lonapegsomatropin and palopegteriparatide. This effort aims to enhance the standard of endocrine diagnosis and treatment in China, enabling more patients to benefit sooner from innovative outcomes that are globally sourced and locally rooted in China.